Fda QSR Jobs

The Software Compliance Engineer role supports the Software Quality Assurance team within Abbott's Diabetes Care division in Alameda, California. This position ensures that medical device software and firmware meet strict regulatory standards, including FDA QSR and ISO guidelines. Key responsibilities include reviewing change plans and test reports to verify compliance, managing defect tracking processes, and serving as a subject matter expert during internal and external audits. The role involves active participation in Agile development cycles and collaboration with cross-functional engineering teams. This opportunity appeals to candidates seeking to contribute to life-changing healthcare technologies while working in a globally recognized company that values diversity and professional growth. The position requires occasional travel and is based at the Alameda facility.

The Systems V&V Engineer role supports high-quality verification and validation activities within a health technology team focused on medical devices. Key responsibilities include executing system-level test plans, translating requirements into test cases for hardware and software, analyzing results to identify risks, and ensuring compliance with regulations like ISO 14971 and FDA standards. This position appeals to candidates seeking to contribute to a mission-driven organization dedicated to improving global healthcare access. The role offers a collaborative environment with opportunities for professional growth and process improvement. It is an office-based position requiring presence at the Malvern, PA facility at least three days per week.

This on-site Research Associate Scientific I role is based in Round Lake, Illinois, supporting a pharmaceutical client's research and development team. The position focuses on conducting critical chemical and physical analyses on finished product stability samples, raw materials, and in-process items using sophisticated laboratory instrumentation. Key responsibilities include performing precise analytical testing, maintaining strict data integrity, ensuring compliance with FDA and cGxP regulations, and troubleshooting laboratory equipment. The role appeals to candidates seeking to contribute directly to patient outcomes through meaningful product development in a regulated environment. It offers an opportunity to work within a collaborative, cross-functional team that values innovation and safety, with potential for project extension beyond the initial 12-month duration.

The Design Quality Engineer I role supports the product development organization at INOVIO, a biotechnology company developing DNA medicines. The position focuses on maintaining compliant design control documentation throughout the product lifecycle to meet QMSR, ISO 14971, and ISO 13485 standards. Key responsibilities include reviewing design plans and verification records, ensuring Design History File completeness, and assisting cross-functional teams with regulatory submissions. This entry-level opportunity offers hands-on experience with medical device compliance frameworks and a collaborative environment where engineers can contribute to life-saving treatments. The role requires a bachelor's degree and 1-2 years of experience in regulated industries, with proficiency in document control systems and risk management tools.

The Associate Design Assurance Quality Engineer role supports product development teams in delivering high-quality medical devices while optimizing core design control processes. Key responsibilities include ensuring compliance with FDA, GMP, and ISO regulations, leading root cause analysis for quality issues, and driving continuous improvement initiatives through risk management and process validation. The position requires cross-functional collaboration with manufacturing, regulatory, and clinical departments to align product requirements with production controls. This opportunity appeals to engineers seeking to work in a fast-paced, regulated environment with a strong focus on innovation and operational excellence. The role offers a collaborative culture, opportunities for professional growth in quality system development, and requires approximately 10% travel.

The Director, Quality Engineering role leads the quality function within BD's global medical technology division, ensuring devices meet rigorous safety and regulatory standards. Key responsibilities include developing strategic quality plans aligned with FDA and ISO requirements, managing and mentoring engineering teams, and overseeing design controls, risk management, and continuous improvement initiatives across the product lifecycle. The position appeals to leaders seeking to drive innovation in healthcare while fostering a collaborative culture that values learning and growth. The role is based in San Diego with a requirement for four days of on-site presence per week to support cross-functional teamwork and operational excellence.

The Manager of Research Blood Cancer role provides leadership for the research program at Sarah Cannon Research Institute, a leading oncology organization dedicated to advancing cancer treatments. The position involves overseeing clinical trial operations, ensuring compliance with FDA and GCP guidelines, and managing fiscal responsibilities including budget monitoring and billing outcomes. Key duties include directing staff recruitment and development, optimizing electronic medical record processes, and analyzing data to improve trial execution and patient care. This position appeals to mission-driven professionals seeking to make a tangible impact on cancer outcomes within a collaborative, community-based environment. The role offers opportunities for professional growth through continuing education and participation in high-impact drug development initiatives.

The Mix Coat Manufacturing Operator II role at LTS Lohmann is a skilled position within the manufacturing team responsible for producing oral and transdermal drug delivery systems. Based in West St. Paul, Minnesota, this second-shift position involves executing equipment setup, operating mixing and coating machinery, and performing in-process quality sampling. Key responsibilities include adhering to strict GMP, FDA, and DEA compliance standards, maintaining accurate production documentation, and supporting continuous process improvements. The role appeals to candidates seeking professional growth within a collaborative environment where they can directly contribute to improving patient outcomes. The position offers a supportive culture focused on teamwork and accountability, with opportunities for development in a global pharmaceutical partner organization.

The Senior Study Startup Specialist role leads complex global clinical trial start-up activities for SystImmune, a well-funded biopharmaceutical company focused on innovative cancer treatments. The position serves as a subject matter expert in site activation, regulatory submissions, and process optimization while mentoring junior team members. Key responsibilities include developing site activation strategies, managing contract and budget negotiations, overseeing CRO deliverables, and ensuring compliance with global regulations like ICH-GCP. This opportunity appeals to professionals seeking to drive continuous improvement in a fast-paced environment with a mission to advance oncology therapies. The role offers a hybrid work arrangement requiring three days onsite at the Princeton, NJ location.

The Deviation Investigation Supervisor role is based in Portsmouth, NH, and involves leading a team of investigators within the Quality Systems department. Key responsibilities include managing team workload, providing technical guidance on complex investigations, and ensuring strict adherence to cGMP standards and regulatory expectations. The position requires cross-functional collaboration with Manufacturing and Quality teams to drive continuous improvement and reduce deviations. This opportunity is appealing for its focus on professional development through mentorship and career planning, as well as the chance to contribute to a global mission of manufacturing life-saving medicines. The role operates on a standard Monday through Friday schedule within a collaborative culture that values accountability and innovation.

The Clinical Research Coordinator role at Huntsman Cancer Institute supports the Principal Investigator in managing the implementation and quality control of cancer research studies across the Intermountain West region. Key responsibilities include ensuring regulatory compliance with FDA and IRB guidelines, managing study budgets and participant enrollment, and coordinating all aspects of patient interactions from screening to informed consent. The position also involves supervising junior staff and maintaining detailed research documentation. This opportunity appeals to professionals seeking to contribute to a mission-driven organization dedicated to reducing the global cancer burden. The role offers a collaborative environment with opportunities for professional growth, requiring a blend of administrative precision and patient-centered care within a hybrid work setting.

The Quality Design Assurance Engineer I or II role serves as a core project team member within Heraeus Medevio, supporting the design and development of complex medical devices such as catheters and guidewires. Key responsibilities include collaborating across functional areas to drive project deliverables, developing quality and risk management plans, reviewing nonconforming products, and ensuring compliance with FDA and ISO regulations. The position offers an opportunity to work in a culture that values curiosity, continuous learning, and growth within a global organization dedicated to improving lives. This is an onsite position based in Fridley, Minnesota, with occasional travel required to the White Bear Lake location.

The Senior Quality Engineer role at Belmar Pharma Solutions ensures products and processes comply with USP, FDA, ISO, and cGMP standards within a leading compounding pharmacy. Key responsibilities include reviewing and approving deviations, investigations, CAPAs, and change controls, while also overseeing validation activities and providing leadership to junior quality engineers. The position offers a collaborative environment focused on wellness and accountability, with opportunities for professional growth through coaching and strategic quality system management. The role is based on-site and requires interaction with cross-functional teams to maintain high clinical support and operational excellence.

This full-time Engineering Technician role supports injection molding operations within PMC SMART Solutions, a contract manufacturer producing life-saving medical devices and automotive components. The position involves executing mold trials, validating processes, and troubleshooting automation systems to ensure production efficiency. Key responsibilities include assisting with tooling setups, monitoring product quality, and collaborating with cross-functional engineering teams to drive continuous improvement initiatives. The role appeals to candidates seeking hands-on technical work in a regulated, high-impact environment where their contributions directly support critical healthcare and safety products. The position offers a collaborative culture focused on operational excellence and offers opportunities for professional growth within a certified, award-winning organization.

The Manufacturing Specialist role serves as a primary process owner and subject matter expert within Evonik's Birmingham Labs, supporting PDS Services and Medical Devices. Key responsibilities include executing cGMP batch manufacturing in cleanroom environments, ensuring regulatory compliance with FDA and EMA standards, and leading training programs for frontline staff. The position also involves managing SOPs, driving continuous improvement, and supporting validation activities. This opportunity appeals to candidates seeking to shape sustainable solutions within a collaborative culture that offers hybrid working flexibility and robust career development. The role is based on-site with shift flexibility required.

The Clinical Trial Monitor II role within the Clinical Trials Office at Dana-Farber Cancer Institute ensures research compliance with federal regulations and institutional policies. Key responsibilities include conducting remote data reviews and onsite monitoring visits to verify data accuracy, developing monitoring plans, and mentoring new team members. The position requires managing multiple projects simultaneously while promoting a culture of regulatory awareness. This opportunity appeals to professionals seeking to contribute to groundbreaking cancer research within an inclusive, mission-driven academic environment. The role is based in Boston with occasional travel required for onsite visits.

The Training Specialist role within the Quality and Compliance department supports the SOFIE network by developing and facilitating educational programs for manufacturing and operational staff. Key responsibilities include assessing training needs, creating individualized and group curricula, delivering face-to-face and virtual workshops, and ensuring compliance with cGMP regulations through collaboration with Quality Assurance and Sterility Assurance teams. The position requires domestic travel to various facilities to conduct hands-on training and manage onboarding processes. This opportunity appeals to candidates seeking a dynamic environment where they can drive organizational growth, implement innovative learning strategies, and contribute to high-quality pharmaceutical production standards.

The Manufacturing Engineer II role supports the medical device team in optimizing clean room processes for products transitioning from new product introduction to commercial manufacturing. Key responsibilities include designing process improvements, managing manufacturing launches, and developing engineering documentation while ensuring compliance with FDA and ISO regulations. The position involves collaborating with cross-functional teams to solve root cause issues and implement robust production methods. This opportunity appeals to candidates seeking a dynamic environment with a focus on quality and efficiency, offering a collaborative culture and comprehensive benefits including flexible time off and paid parental leave.

This Management Consulting Associate role within RSM's Life Sciences practice supports middle market organizations in solving complex operational and business challenges. Key responsibilities include analyzing data to define current-state operations, developing recommendations for quality and regulatory improvements, and creating client deliverables such as process maps and presentations. The position offers a collaborative environment with exposure to diverse engagements across the Life Sciences value chain, fostering professional growth alongside experienced leaders. The role appeals to candidates seeking a culture that empowers personal and professional development while offering schedule flexibility to balance work and life. Travel is required approximately 25% of the time to support client engagements.

This full-time Warehouse Clerk role operates on the second shift at Kenco Logistics, a leading third-party logistics provider. The position focuses on inventory control and shipping operations, with key responsibilities including reading customer orders, preparing materials for shipment, creating shipping documentation, and performing daily cycle counts to verify physical inventory against system records. The role requires utilizing warehouse management systems and maintaining a clean, safety-compliant work environment. The position appeals to candidates seeking a supportive culture that values innovation, integrity, and employee growth within the supply chain industry. It offers a stable career path with opportunities for continuous improvement and professional development in a non-travel environment.

This full-time second-shift warehouse associate role at Kenco Logistics involves picking, packing, and preparing orders for shipment within a supportive 3PL environment. Key responsibilities include measuring and weighing products, operating equipment like forklifts, affixing shipping labels, and conducting quality inspections to ensure accuracy and safety compliance. The position appeals to candidates seeking a career in the supply chain industry with a focus on continuous improvement and operational excellence. The role offers a collaborative culture that values employee growth, comprehensive benefits including health insurance and paid time off, and a stable work arrangement with no travel requirements.

This Project Engineer role at Globus Medical focuses on developing innovative surgical instruments and implants to improve patient outcomes for musculoskeletal disorders. The position involves designing products using Creo and SolidWorks, managing project plans and FDA Design History Files, and gathering market feedback from surgeons to define specifications. Key responsibilities include overseeing design verification, coordinating with prototype shops and vendors, and supporting product launches through sales training. The role appeals to candidates seeking to contribute to a mission-driven culture that values innovation, teamwork, and rapid response to customer needs. The position requires a blend of mechanical design expertise and regulatory knowledge within a deadline-driven environment.

This Senior Manager role within the Oncology Clinical Development team provides scientific oversight for clinical trials supporting the company's cancer treatment portfolio. Key responsibilities include ensuring data integrity and quality, authoring critical regulatory documents such as protocols and informed consent forms, and leading data review strategies to analyze emerging safety profiles. The position involves collaborating with cross-functional partners to drive study execution and presenting findings to governance bodies. The role is appealing for its opportunity to contribute directly to patient care through impactful oncology research, offering a collaborative environment that values innovation and global perspectives. This hybrid position requires on-site presence approximately 2.5 days per week.

This full-time Industrial Sewing Operator role, located in Chanhassen, Minnesota, involves operating industrial sewing machines to assemble medical device components from materials like lamb's wool pelts. Key responsibilities include following strict production specifications, inspecting finished products for quality and consistency, and maintaining accurate FDA and ISO-regulated documentation. The position offers a path to permanent employment with a supportive team culture that includes monthly on-site meals. The role requires prior sewing experience and strong manual dexterity, operating on a standard weekday schedule from 7:00 am to 3:00 pm.

This full-time Clinical Research Coordinator role supports the Division of Urology within the Department of Surgery, managing operations for both adult and pediatric research programs. Key responsibilities include overseeing research procedures, ensuring regulatory compliance, managing data acquisition and entry, and coordinating patient screening and follow-up. The position also involves assisting with IRB protocol development and participating in grant submissions. The role appeals to organized professionals seeking to contribute to impactful medical research in a collaborative environment. It requires strong communication skills and the ability to work independently within an office setting.